Status:
ACTIVE_NOT_RECRUITING
Trimethylamine N-oxide Effects of a Pomegranate Supplement Simultaneously With Carnitine (TESSA)
Lead Sponsor:
Quadram Institute Bioscience
Collaborating Sponsors:
Norfolk and Norwich University Hospitals NHS Foundation Trust
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Trimethylamine N-oxide (TMAO) is produced in some individuals whose diets include meat, fish, and dairy.These foods are rich in L-carnitine. L-carnitine is metabolised by the liver and gut microorgani...
Detailed Description
The TESSA study is a 18 day randomised, double-blind, placebo-controlled two-arm crossover pilot study conducted at the NIHR (National Institute for Health and Care Research) Norfolk Clinical Research...
Eligibility Criteria
Inclusion
- Inclusion criteria (First phase):
- Individuals who regularly eat meat (4 portions of meat per week for at least 2 months prior to enrolment in the study).
- Aged 18 and older.
- Body Mass Index (BMI) between 18.5 - 30 kg/m2.
- Living within 40 miles from the Norwich Research Park.
- Inclusion criteria (Second phase)
- meets first phase inclusion criteria
- TMAO producer (plasma TMAO increase of \>5 µM and \>50% after L-carnitine ingestion.
- Exclusion criteria:
- Consume an entirely vegan, vegetarian, or pescatarian diet within the last two months.
- Do not have access to a freezer to store some provided meals and ice packs.
- Have a known allergy to the tablets, capsules (i.e., pomegranate), or standardised meals such as wheat, eggs, milk, nuts, and soybeans.
- Have difficulty swallowing, a swallowing disorder, or are unable to swallow four capsules (the size of a peanut) and three L carnitine tablets consecutively within a time span of ten minutes.
- Have bowel movements less than five times a week.
- Are a current smoker (or stopped smoking for less than 3 months).
- Consume more than 14 units of alcohol per week (for example, a pint of beer or a 175 mL glass of wine each count as two units).
- Are pregnant or breastfeeding.
- Have anaemia or any conditions or medications that may hinder clotting. This will be assessed on a case-by-case basis.
- Have high or low blood pressure (i.e., ≤90/60 or ≥160/100 mmHg).
- Have a medical condition or take medications that may affect the primary outcome of this study, such as but not limited to diabetes, liver disease, hypo/hyperthyroidism, or fish odour syndrome. This will be assessed on a case-by-case basis.
- Have had gastrointestinal disease or surgical procedures that may affect the primary outcome of this study. This will be assessed on a case-by-case basis.
- Have known or a history of kidney disease, this will be determined by the medical advisor using blood urea nitrogen and creatinine levels in the participant's blood.
- Regularly use bowel cleansing techniques like colonic irrigation or laxatives.
- Had an infection or received antibiotics within a month prior to this study.
- Regularly take dietary supplements that may affect the primary outcome measure of this study, such as fish oil or L carnitine supplements.
- Are currently undergoing active treatment for cancer or heart disease.
- Participated in another dietary intervention study within the last four months.
- Have donated a large quantity of blood within the last 16 weeks. Registered donors should abstain from blood donations for the duration of the study.
- Are a person related to or living with a member of the study team.
- Are unable to give written or verbal informed consent.
- Participant is unable to provide GP (General Practitioner) contact details.
- Have symptoms of Coronavirus infection (COVID-19), been asked to self-isolate, or have been diagnosed with COVID-19 in the last 14 days.
Exclusion
Key Trial Info
Start Date :
August 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2027
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT06518343
Start Date
August 12 2024
End Date
May 31 2027
Last Update
June 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Quadram Institute
Norwich, Norfolk, United Kingdom, NR4 7UQ